| CTRI Number |
CTRI/2014/10/005076 [Registered on: 07/10/2014] Trial Registered Prospectively |
| Last Modified On: |
12/08/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Clinical evaluation of Diabepal tablet in comparison with Placebo tablet in Type 2 Diabetic Patients |
|
Scientific Title of Study
|
A Clinical Evaluation of Efficacy and Safety of Tablet DIABEPAL as an Add-on therapy with Oral Hypoglycemic Agent (OHA) in Type 2 Diabetic Patients - A Randomized, Single-center, Double Blind, Placebo Controlled Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AH/DBPL/01/2014, V1 (07.07.2014) |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shrikant Gunvantrao Deshmukh |
| Designation |
Principal and H.O.D. PG Department of Kayachikitsa |
| Affiliation |
C.S.M.S.S. Ayurveda College Kanchanwadi, Aurangabad |
| Address |
C.S.M.S.S. Ayurveda College Kanchanwadi, Aurangabad
Aurangabad
MAHARASHTRA
431005
India |
| Phone |
9921553999 |
| Fax |
|
| Email |
sgdagd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Arjun Kohli |
| Designation |
Director |
| Affiliation |
ARJUN HEALTHCARE |
| Address |
ARJUN HEALTHCARE
11, Krypton towers,
New Prabhadevi Road,
Prabhadevi, Mumbai
Mumbai
MAHARASHTRA
400025
India |
| Phone |
8108829777 |
| Fax |
|
| Email |
arjunhealthcare2012@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arjun Kohli |
| Designation |
Director |
| Affiliation |
ARJUN HEALTHCARE |
| Address |
ARJUN HEALTHCARE
11, Krypton towers,
New Prabhadevi Road,
Prabhadevi, Mumbai
MAHARASHTRA
400025
India |
| Phone |
8108829777 |
| Fax |
|
| Email |
arjunhealthcare2012@gmail.com |
|
|
Source of Monetary or Material Support
|
| Arjun Healthcare 11 Krypton towers New Prabhadevi Road,
Prabhadevi Mumbai
|
|
|
Primary Sponsor
|
| Name |
Arjun Healthcare |
| Address |
11 Krypton towers New Prabhadevi Road, Prabhadevi Mumbai |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shrikant Gunvantrao Deshmukh |
OPD of Kayachikitsa |
OPD of Kayachikitsa C.S.M.S.S. Ayurveda College Kanchanwadi, Aurangabad
Aurangabad
MAHARASHTRA |
9921553999
sgdagd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, C.S.M.S.S. Ayurveda College Kanchanwadi, Aurangabad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Type 2 Diabetes Mellitus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
DIABEPAL TABLET |
It contains Gudmar Ext (Gymnema sylvestrae), Vijaysaar Ext (Pterocarpus marcipium), Methi Ext (Trigonella foenum graecum), Jamun Ext (Eugenia jambolana), Karela Ext (Momordica charainta), Pippali Ext (Piper longum)
Dosage and Treatment duration: 2 tablets twice daily orally for 3 months
|
| Comparator Agent |
Placebo Tablet |
Matching Placebo tablet will be prepared using approved excipients.
Dosage and Treatment duration: 2 tablets twice daily orally for 3 months
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects suffering from Type 2 Diabetes Mellitus for more than one year,
2. Subject stabilized on mono/ polydrug anti-diabetic therapy for at least last 3 months.
3. Subjects having their fasting blood glucose in the range of 126 -252 mg/dl on screening visit
4. HbA1C in range of 7-11%
5. Subject’s ECG not demonstrating any signs of uncontrolled arrhythmia / acute ischemia
6. Subjects with controlled blood pressure and controlled lipid levels
|
|
| ExclusionCriteria |
| Details |
1.Subjects on insulin therapy
2.Subjects suffering from type-1 DM or types of Diabetes mellitus other than Type -2
3.Subjects having known hepatic or renal disease
4.Subjects having an active malignancy
5.Subjects with history of significant cardiovascular event < 12 weeks prior to randomization
6.Subjects having known major complications of Diabetes like Ketoacidosis, Nephropathy, Neuropathy, Retinopathy, and Diabetic wounds
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Monthly changes in fasting & postprandial plasma glucose levels
2.Changes in HbA1C% (Glycosylated Hemoglobin) value
|
Baseline value, value on 30th day, 60th day, and 90th day of treatment
2.Changes in HbA1C% (Glycosylated Hemoglobin) value
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Quality of Life (QOL) of patients will be done using WHO-QOL
2.Changes in Serum insulin level
3.Reduction or increase in dose of OHAs
4.Clinical symptoms of Type 2 DM i.e. Polydypsia, Polyphasia, Polyurea, & fatigue
5.Global assessment for overall improvement will be done by the investigator and by the patient himself / herself on study completion
|
Baseline value, value on 30th day, 60th day, and 90th day of treatment
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/10/2014 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="12"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NOT YET DONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a
Randomized, Single-center, Double Blind, Placebo Controlled Study to Evaluate Efficacy
and Safety of Tablet DIABEPAL as an Add-on therapy with Oral Hypoglycemic Agent
(OHA) in Type 2 Diabetic Patients. Study will be conducted in 80 subjects (40
subjects in each group) in India. The primary outcome measures will be assessment
of monthly changes in fasting & postprandial plasma glucose levels
[baseline value, value on 30th day, 60th day, and 90th day of treatment] and assessment
of changes in HbA1C% (Glycosylated Hemoglobin) value [from baseline to end of
study value]. The secondary objectives would be assessment of Quality of Life
(QOL) of patients will be done using WHO-QOL (brief) questionnaire (Appendix-D)
[from baseline visit and on every alternate follow-up visit viz. Visit-II (day
30), Visit-IV (day 60) and Visit-VI (day 90)], changes in Serum insulin level
[from baseline to end of study value], reduction or increase in dose of OHAs [from
baseline to end of study], clinical symptoms of Type 2 DM i.e. Polydypsia, Polyphagia,
Polyuria, & fatigue (refer appendix-C) [Time frame: 3 months], Global assessment
for overall improvement will be done by the investigator and by the patient
himself / herself on study completion and assessment of safety. Tablet diabepal
and matching placebo will be administered in a dose of 2 tablets twice daily
orally along with OHAs for 3 months.
|